Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...

The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...

This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section,...

ISPE has released three new Guidance Documents:
Good Practice Guide: Single-Use Technology provides a road map for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. From this Guide, users will learn...

Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.

Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for...

Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo on 4–7 November. Highlights below show the many ways that presenters captured the conference theme of “Vision to Reality”: in strides against disease, ISPE’s advancements over the last...

On sitting down to write my first Chair’s column, I reflected on the events at our Annual Meeting & Expo in November. First, I want to commend the entire ISPE organization, and offer particular thanks to the 2018 Annual Meeting planning committee, for...